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Aspirin

Generic Name
Aspirin
Brand Names
Aggrenox, Alka-seltzer, Alka-seltzer Fruit Chews, Anacin, Arthriten Inflammatory Pain, Ascomp, Aspi-cor, Aspir-low, Bayer Aspirin, Bayer Womens, Bc Arthritis, Bc Original Formula, Bufferin, Duoplavin, Durlaza, Ecotrin, Ecpirin, Endodan Reformulated May 2009, Equagesic, Exaprin, Excedrin, Excedrin PM Triple Action, Fasprin, Fiorinal, Goody's Body Pain, Goody's Extra Strength, Goody's PM, Miniprin, Norgesic, Norgesic Forte, Orphengesic, Pamprin Max Formula, Robaxisal, ST. Joseph Aspirin, Stanback Headache Powder Reformulated Jan 2011, Trianal, Trianal C, Vanquish, Vazalore, Yosprala, DuoPlavin, Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)
Drug Type
Small Molecule
Chemical Formula
C9H8O4
CAS Number
50-78-2
Unique Ingredient Identifier
R16CO5Y76E

Overview

Also known as Aspirin, acetylsalicylic acid (ASA) is a commonly used drug for the treatment of pain and fever due to various causes. Acetylsalicylic acid has both anti-inflammatory and antipyretic effects. This drug also inhibits platelet aggregation and is used in the prevention of blood clots stroke, and myocardial infarction (MI) . Interestingly, the results of various studies have demonstrated that long-term use of acetylsalicylic acid may decrease the risk of various cancers, including colorectal, esophageal, breast, lung, prostate, liver and skin cancer . Aspirin is classified as a non-selective cyclooxygenase (COX) inhibitor and is available in many doses and forms, including chewable tablets, suppositories, extended release formulations, and others . Acetylsalicylic acid is a very common cause of accidental poisoning in young children. It should be kept out of reach from young children, toddlers, and infants .

Indication

Pain, fever, and inflammation Acetylsalicylic acid (ASA), in the regular tablet form (immediate-release), is indicated to relieve pain, fever, and inflammation associated with many conditions, including the flu, the common cold, neck and back pain, dysmenorrhea, headache, tooth pain, sprains, fractures, myositis, neuralgia, synovitis, arthritis, bursitis, burns, and various injuries. It is also used for symptomatic pain relief after surgical and dental procedures . The extra strength formulation of acetylsalicylic acid is also indicated for the management migraine pain with photophobia (sensitivity to light) and phonophobia (sensitivity to sound). Other indications ASA is also indicated for various other purposes, due to its ability to inhibit platelet aggregation. These include: Reducing the risk of cardiovascular death in suspected cases of myocardial infarction (MI) . Reducing the risk of a first non-fatal myocardial infarction in patients, and for reducing the risk of morbidity and mortality in cases of unstable angina and in those who have had a prior myocardial infarction . For reducing the risk of transient ischemic attacks (TIA) and to prevent atherothrombotic cerebral infarction (in conjunction with other treatments) . For the prevention of thromboembolism after hip replacement surgery . For decreasing platelet to platelet adhesion following carotid endarterectomy, aiding in the prevention of transient ischemic attacks (TIA) . Used for patients undergoing hemodialysis with a silicone rubber arteriovenous cannula inserted to prevent thrombosis at the insertion site . Important note regarding use of the extended-release formulation In the setting of acute myocardial infarction, or before percutaneous interventions, the extended-release form of acetylsalicylic acid should not be used. Use immediate-release formulations in scenarios requiring rapid onset of action . The extended-release form is taken to decrease the incidence of mortality and myocardial infarction (MI) for individuals diagnosed with chronic coronary artery disease (CAD), including patients with previous myocardial infarction (MI) or unstable angina or with chronic stable angina. Additionally, the extended-release form is used to decrease the risk of death and recurrent episodes of stroke in patients with a history of stroke or TIA .

Associated Conditions

  • Acute Coronary Syndrome (ACS)
  • Anxiety
  • Atherothrombotic cerebral infarction
  • Cardiovascular Disease (CVD)
  • Cardiovascular Events
  • Cardiovascular Mortality
  • Colorectal Adenomas
  • Colorectal Cancer
  • Common Cold
  • Coronary artery reocclusion
  • Death
  • Dyspeptic signs and symptoms
  • Fever
  • Flu caused by Influenza
  • Headache
  • Heterozygous Familial Hypercholesterolemia (HeFH)
  • Inflammation
  • Juvenile Idiopathic Arthritis (JIA)
  • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
  • Menstrual Pain
  • Migraine
  • Morbidity
  • Mucocutaneous Lymph Node Syndrome
  • Muscle Contraction
  • Myalgia
  • Myocardial Infarction
  • Myocardial Infarction (MI), first occurrence
  • Neuropathic Pain
  • Pain
  • Pain caused by Common Cold
  • Pain caused by Rheumatism
  • Pericarditis
  • Polycythemia Vera (PV)
  • Pre-Eclampsia
  • Rheumatism
  • Rheumatoid Arthritis
  • Rhino Sinusitis
  • Severe Pain
  • Spondyloarthropathies
  • Stroke
  • Systemic Lupus Erythematosus
  • Tension Headache
  • Thromboembolism
  • Thrombosis
  • Toothache
  • Transient Ischemic Attack
  • Vascular Death
  • Venous Thromboembolism
  • Acute Inflammation
  • Articular inflammation
  • Atherothrombotic events
  • Death caused by Myocardial Infarction
  • Fever or influenza-like illness
  • Moderate Pain
  • Recurrent Ischemic Stroke

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2024/06/11
Phase 4
Not yet recruiting
Shanghai Zhongshan Hospital
2024/06/10
Not Applicable
Active, not recruiting
2024/06/05
Phase 1
Completed
2024/05/16
Phase 1
Recruiting
Instituto Nacional de Investigacao em Saude, Angola
2024/05/10
Phase 3
Recruiting
2024/04/25
Early Phase 1
Not yet recruiting
2024/04/22
Early Phase 1
Recruiting
2024/03/28
N/A
Recruiting
Anhui Medical University
2024/02/28
Phase 4
Recruiting
Alisse Hauspurg
2024/02/28
Phase 4
Withdrawn

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
H.J. Harkins Company
52959-370
ORAL
325 mg in 1 1
1/3/2012
Preferred Pharmaceuticals Inc.
68788-4028
ORAL
81 mg in 1 1
9/22/2025
Pharmadel LLC
55758-363
ORAL
325 mg in 1 1
4/8/2025
Kroger Company
30142-654
ORAL
500 mg in 1 1
4/29/2025
Parasitology Center Inc.
70321-0003
ORAL
10 [hp_X] in 1 mL
5/22/2025
Amerisource Bergen
24385-365
ORAL
250 mg in 1 1
8/26/2025
Rite Aid Corporation
11822-6451
ORAL
81 mg in 1 1
8/27/2025
Bryant Ranch Prepack
71335-1774
ORAL
81 mg in 1 1
3/31/2025
Vensun Pharmaceuticals, Inc.
42543-098
ORAL
325 mg in 1 1
10/3/2016
LGM PHARMA SOLUTIONS, LLC
79739-6094
ORAL
325 mg in 1 1
5/13/2022

EMA Drug Approvals

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Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Number
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Company
Licence No.
Strength
Registration Date
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TGA Drug Approvals

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Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ENTROPHEN
pendopharm division of pharmascience inc
02242281
Tablet (Delayed-Release) - Oral
81 MG
6/20/2000
ACETYLSALICYLIC ACID STOMACH PROTECTION 325MG TABLETS
cellchem pharmaceuticals inc.
02255847
Tablet - Oral
325 MG
N/A
ASPIRIN EXTRA STRENGTH WITH STOMACH GUARD
Bayer Inc
02278316
Tablet - Oral
500 MG
N/A
ASTRIN 5GR
medic laboratory ltée
00134376
Tablet (Enteric-Coated) - Oral
325 MG / TAB
12/31/1959
C2 BUFFERED WITH CODEINE TAB
wampole brands, a division of pangeo pharma (canada) inc.
00693979
Tablet - Oral
325 MG
12/31/1986
APO ASA TAB 325MG
00472468
Tablet - Oral
325 MG
12/31/1989
PERCODAN
bristol-myers squibb canada
01916572
Tablet - Oral
325 MG
12/31/1958
ADALAT XL PLUS
Bayer Inc
02313774
Tablet (Extended-Release) ,  Tablet (Delayed-Release) ,  Kit - Oral
81 MG
7/24/2008
PAL-PRAVASTATIN-ASA
paladin pharma inc.
02272415
Kit ,  Tablet ,  Tablet (Delayed-Release) - Oral
81 MG
1/13/2006
282 TABLETS
pendopharm division of pharmascience inc
02234510
Tablet - Oral
375 MG
11/1/1998

CIMA AEMPS Drug Approvals

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Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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License Number
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Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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MA Holder
MA Number
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Active Ingredient
Authorization Date
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